Leica Aperio GT 450 DX User manual

Aperio GT 450 DX
User’s Guide
MAN-0475, Revision B | May 2022

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 20222
Aperio GT 450 DX User’s Guide
This manual applies to Aperio GT 450 DX Controller, Aperio GT 450 DX Console, and Aperio GT 450 DX SAM DX
versions 1.1 and later
Copyright Notice
ÌCopyright © 2022 Leica Biosystems Imaging, Inc. All Rights Reserved. LEICA and the Leica logo are registered trademarks of Leica
Microsystems IR GmbH. Aperio, GT, and GT 450 are trademarks of Leica Biosystems Imaging, Inc. in the USA and optionally in other
countries. Other logos, products, and/or company names might be trademarks of their respective owners.
ÌThis product is protected by registered patents. For a list of patents, contact Leica Biosystems.
Customer Resources
ÌFor the latest information on Leica Biosystems Aperio products and services, please visit www.LeicaBiosystems.com/Aperio.
Contact Information – Leica Biosystems Imaging, Inc.
Headquarters Customer Support General Information
Leica Biosystems Imaging, Inc.
1360 Park Center Drive
Vista, CA 92081
USA
Tel: [phone] (toll free)
Direct International Tel: [phone]
Contact your local support
representative with any query and
service request.
https://www.leicabiosystems.com/
service-support/technical-support/
US/Canada Tel: [phone] (toll free)
Direct International Tel: [phone]
Email: [email protected]
European Union Authorized Representative United Kingdom Responsible Person
CEpartner4U
Esdoornlaan 13
3951 DB Maarn
The Netherlands
Leica Microsystems (UK) Limited
Larch House, Woodlands Business Park
Milton Keynes, England, United Kingdom, MK14 6FG
Importers
Leica Biosystems Deutschland GmbH
Heidelberger Straße 17-19
69226 Nussloch, Germany
Leica Microsystems (UK) Limited
Larch House, Woodlands Business Park
Milton Keynes, England, United Kingdom, MK14 6FG
00815477020297, 00815477020389
23GT450DXIVD, 23SAMSWDXIVD

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 3
Notices...................................................................................................................................... 7
Revision Record .............................................................................................................................7
Cautions and Notes ........................................................................................................................7
Intended Purpose...........................................................................................................................8
Symbols........................................................................................................................................8
Customer Service Contacts ........................................................................................................11
1 Introduction........................................................................................................................ 13
Resources ...................................................................................................................................14
Warnings.....................................................................................................................................14
Electromagnetic Warnings .........................................................................................................14
Instrument Warnings.................................................................................................................15
Component and Part Replacement Warnings................................................................................15
Compliance Specications ............................................................................................................15
Installation .................................................................................................................................16
Disposal of the Aperio GT 450 DX...................................................................................................17
Device Lifetime ............................................................................................................................17
Scanner Safety Instructions...........................................................................................................17
2 Aperio GT 450 DX Overview.................................................................................................. 20
Theory of Operation......................................................................................................................20
Scanner Overview.........................................................................................................................21
Turn the Scanner On and Off ......................................................................................................22
Touchscreen Interface Overview.....................................................................................................22
Home Screen ...........................................................................................................................23
Help Videos and Guides ................................................................................................................25
Key Features................................................................................................................................25
Continuous Load Workow ........................................................................................................25
Scan Magnication ...................................................................................................................25
Automatic Image Quality Check..................................................................................................25
Image Types Supported .............................................................................................................26
Slide Types Supported...............................................................................................................26
Contents

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 20224
Contents
Coverslips................................................................................................................................26
Slide Racks Supported...............................................................................................................26
Slide Capacity ..........................................................................................................................26
Barcodes Supported..................................................................................................................26
3 Slide Preparation ................................................................................................................ 27
Tissue Preparation .......................................................................................................................27
Staining ......................................................................................................................................27
Slide Preparation Guidelines ..........................................................................................................27
Tissue Placement..................................................................................................................28
Fixing Slide Preparation Errors ................................................................................................28
Coverslips ...................................................................................................................................28
Labels.........................................................................................................................................29
Barcodes.....................................................................................................................................29
4 Scan Slides ........................................................................................................................ 30
Scanning Concepts.......................................................................................................................30
Scan Workow .........................................................................................................................30
Carousel Rotation .....................................................................................................................31
Log In and Log Out of the Scanner..................................................................................................31
Load Slides in the Rack .................................................................................................................32
Load Racks in the Carousel ...........................................................................................................33
Priority Scanning..........................................................................................................................35
Rotate a Rack to the Rack Loading Area ..........................................................................................36
Unload Racks from the Carousel ....................................................................................................38
Check Scan Status .......................................................................................................................39
Check Rack Status....................................................................................................................39
Rack Error on Current Scan.....................................................................................................39
View Slide Status for a Rack.......................................................................................................40
View Macro Images of Scanned Slides ........................................................................................41
View Rack Scan Order ...............................................................................................................41
Rack Warnings .........................................................................................................................42
Scan Entire Slide for Whole Rack....................................................................................................43
Image Quality Control for Histotechnicians and Pathologists .............................................................45
Scan Statistics.............................................................................................................................45
5 Maintenance....................................................................................................................... 46
Maintenance Schedule..................................................................................................................46
Serial Number and Firmware Version ..............................................................................................47
Shut Down the Scanner .................................................................................................................47
Open the Scanner Cover and Access the Interior Components............................................................48

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 5
Contents
Recommended Daily Maintenance..................................................................................................50
Restart the Scanner ..................................................................................................................50
Six Month Maintenance.................................................................................................................51
Clean the Objective and Koehler .................................................................................................51
Materials Needed..................................................................................................................51
Clean the Stage Slide Tray..........................................................................................................54
Clean the Carousel....................................................................................................................55
Clean the Fan Filter ...................................................................................................................55
Clean the Slide Racks................................................................................................................57
Clean the Scanner Cover............................................................................................................57
Clean the Touchscreen ..............................................................................................................58
Restart the Scanner After Interior Maintenance................................................................................58
Transporting or Moving the Aperio GT 450 DX..................................................................................59
Long Term Storage .......................................................................................................................59
6 Troubleshooting.................................................................................................................. 60
Personal Protective Equipment ......................................................................................................60
Red Blinking Lights on Carousel .....................................................................................................60
How to Use the Troubleshooting Steps............................................................................................60
Perform a Safe Restart After an Error..............................................................................................61
Error Codes and Solutions .............................................................................................................63
1000: Internal error ...................................................................................................................63
1001: Scanner cannot initialize...................................................................................................65
1002: Carousel cannot rotate .....................................................................................................67
1003: Carousel cannot rotate. Carousel pinch point obstructed. .....................................................69
1007: Internal storage full. Cannot send images to DICOM converter...............................................69
2000: Slide handling error at slide stage, rack, or pusher................................................................69
2001: Slide handling error at rack gripper, lift, or carousel. .............................................................72
9000: Scanner cover is open ......................................................................................................74
Rack Warnings and Solutions.........................................................................................................74
1005: Cannot process rack.........................................................................................................74
1006: Cannot process one or more slides in rack. .........................................................................75
Slide Errors and Solutions..........................................................................................................76
Tilted Slide(s) .......................................................................................................................76
No Barcode ..........................................................................................................................77
No Tissue.............................................................................................................................77
No Macro Focus....................................................................................................................77
Image Quality .......................................................................................................................78
Image Transfer Error – Pending Retry.......................................................................................79
Aborted ...............................................................................................................................79
Aborted Message Appears on All Slides...................................................................................80

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 20226
Contents
Symptoms and Solutions...............................................................................................................81
Scanner Does Not Power On ......................................................................................................81
Touchscreen Does Not Respond to Touch ....................................................................................81
Touchscreen is Black ................................................................................................................81
Slides are Broken inside the Scanner...........................................................................................82
Internet Connection Lost ...........................................................................................................82
A Performance Information................................................................................................. 83
Analytical Performance.................................................................................................................83
Trueness .................................................................................................................................83
Precision (Repeatability and Reproducibility)................................................................................84
Accuracy (Resulting from Trueness and Precision)........................................................................84
Clinical Performance ....................................................................................................................85
Index....................................................................................................................................... 86

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 7
Notices
Revision Record
Rev. Issued Sections
Affected Detail
B May 2022 Page 75 Corrected a typographical error.
A April 2022 All New version for Aperio GT 450 DX product. Based on existing
Aperio GT 450 DX Scanner User’s Guide, MAN-0458, Revision A
Cautions and Notes
`Serious Incidents Reporting - Any serious incident that has occurred in relation to the Aperio GT 450 DX shall be
reported to the manufacturer and the competent authority of the member state in which the user and/or the patient
is established.
`Specications and Performance - For device specications and performance characteristics, refer to the document
Aperio GT 450 DX Specications.
`Installation - Aperio GT 450 DX must be installed by a trained Leica Biosystems Technical Services representative.
`Repair - Repairs may be done only by a trained Leica Biosystems Technical Services representative. After repairs
are done, ask the Leica Biosystems technician to perform operation checks to determine the product is in good
operating condition.
`Accessories - For information on using Aperio GT 450 DX with third-party accessories such as a Laboratory
Information System (LIS) not provided by Leica Biosystems, contact your Leica Biosystems Technical Services
representative.
`Quality Control -For information on image quality checks, see, “Image Quality Control for Histotechnicians and
Pathologists” on page 45.
`Maintenance and Troubleshooting -For information on maintenance, see “Chapter 5: Maintenance” on page
46. For information on troubleshooting problems, see “Chapter 6: Troubleshooting” on page 60.
`Cybersecurity - Be aware that workstations are susceptible to malware, viruses, data corruption, and privacy
breaches. Work with your IT administrators to protect workstations by following your institution’s password and
security policies.
To protect workstations from malware intrusion, use caution when inserting USB drives and other removable
devices. Consider disabling USB ports that are not in use. If you plug in a USB drive or other removable device, you
should scan the devices with an anti-malware utility. For Aperio recommendations on protecting your workstations
and servers, see the document Aperio GT 450 DX IT Manager and Lab Administrator Guide.
If a suspected Aperio GT 450 DX cybersecurity vulnerability or incident is detected, contact Leica Biosystems
Technical Services for assistance.
`Training - This manual is not a substitute for the detailed operator training provided by Leica Biosystems or for other
advanced instruction.
`Safety - Safety protection may be impaired if this device is used in a manner not specied by the manufacturer.

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 20228
Intended Purpose
The Aperio GT 450 DX is a device for creation of digital images of scanned surgical pathology glass slides prepared from
formalin-xed paran embedded (FFPE) tissue that would otherwise be appropriate for manual visualization by conventional
light microscopy. Aperio GT 450 DX is intended for in vitro diagnostic use with compatible viewing software and display that
has been validated for use with this scanner as an aid to the pathologist in the qualitative review and interpretation of digital
images.
The Aperio GT 450 DX is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is
the responsibility of a qualied pathologist to employ appropriate procedures and safeguards to assure the validity of the
interpretation of images obtained using the Aperio GT 450 DX.
Symbols
The following symbols appear on your product label or in this user guide.
Symbol Regulation/
Standard Description
ISO 15223-1 - 5.4.3 Consult the instructions for use.
ISO 15223-1 - 5.1.1 Manufacturer
ISO 15223-1 - 5.1.3 Date of manufacture
ISO 15223-1 - 5.1.2 European Union Authorized Representative
ISO 15223-1 - 5.1.8 Importer
AS/NZS 4417.1
Device is in compliance with with the Australian Communications Media
Authority (ACMA) requirements (safety and EMC) for Australia and New
Zealand.
ISO 15223-1 - 5.1.7 Serial number
ISO 15223-1 – 5.5.1 In Vitro Diagnostic medical device.
ISO 15223-1 – 5.1.6 Catalog number
ISO 15223-1 – 5.7.10 Unique Device Identier
EU 2017/746
Article 18
Device carries the CE (Conformité Europëenne) Mark and fulls the
requirements of EU Regulation 2017/746.

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 9
Symbol Regulation/
Standard Description
Medical Devices
Regulations 2002 Device is in compliance with UK Conformity Assessment requirements.
ISO 15223-1 - 5.4.4 Caution
SO 7010 – W001 General warning
IEC 61010-1 TÜV Product Services have certied that the listed products comply with both
U.S. and Canadian safety requirements.
IEC 60417 - 5031 This device is suitable for direct current only.
IEC 60417 - 5007 On. To indicate connection to the mains, at least for mains switches or their
positions, and those cases where safety is involved.
IEC 60417 - 5008 Off. To indicate disconnection from the mains, at least for mains switches, and
all those cases where safety is involved.
ISO 15523-1 5.7.3 Temperature limitation
ISO 15223-1 5.3.8 Humidity limitation
2012/19/EU Device is regulated under 2012/19/EU (WEEE Directive) for Electrical and
Electronic Equipment Waste and must be discarded under special conditions.
People’s Republic
of China Electronic
Industry Standard SJ/
T11364
Device contains certain toxic or hazardous elements and can be used safely
during its environmental protection use period. The number in the middle of
the logo indicates the environmental protection use period (in years) for the
product. The outer circle indicates that this product can be recycled.

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 202210
Symbol Regulation/
Standard Description
IEC 60825-1 Device is a Class 1 Laser Product that is in compliance with international
standards and US requirements.
CA Proposition 65
This product can expose you to chemicals known to the State of California to
cause Cancer and Reproductive Harm. For more information go to https://www.
P65Warnings.ca.gov.
N/A Device is made in the USA of US and foreign components.

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 11
Customer Service Contacts
Please contact the oce for your country for technical assistance.
Australia:
96 Ricketts Road
Mount Waverly, VIC 3149
AUSTRALIA
Tel: [phone] (toll free)
Between 8:30 AM-5 PM, Monday-Friday, AEST
Email: [email protected]
Austria:
Leica Biosystems Nussloch GmbH
Technical Assistance Center
Heidelberger Strasse 17
Nussloch 69226
GERMANY
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: suppor[email protected]
België/Belgique:
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: suppor[email protected]
Canada:
Tel: [phone] (toll free)
Direct International Tel: [phone]
Email: T[email protected]
China:
17F, SML Center No. 610 Xu Jia Hui Road, Huangpu
District
Shanghai, PRC PC:200025
CHINA
Tel: [phone]
Fax: [phone]
Email: [email protected]
Remote Care email: [email protected]
Danmark:
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: suppor[email protected]
Deutschland:
Leica Biosystems Nussloch GmbH
Technical Assistance Center
Heidelberger Strasse 17
Nussloch 69226
GERMANY
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: suppor[email protected]
Eire:
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: suppor[email protected]
España:
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: suppor[email protected]
France:
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: suppor[email protected]
Italia:
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: suppor[email protected]
Japan:
1-29-9 Takadanobaba, Shinjuku-ku
Tokyo 169-0075
JAPAN
Nederland:
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: suppor[email protected]

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 202212
New Zealand:
96 Ricketts Road
Mount Waverly, VIC 3149
AUSTRALIA
Tel: [phone] (toll free)
Between 8:30 AM-5 PM, Monday-Friday, AEST
Email: [email protected]
Portugal:
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: suppor[email protected]
The Russian Federation
BioLine LLC
Pinsky lane 3 letter A
Saint Petersburg 197101
THE RUSSIAN FEDERATION
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: [email protected]
Sweden:
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: suppor[email protected]
Switzerland:
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: suppor[email protected]
United Kingdom:
Tel: [phone] (toll free)
In-country Tel: [phone]
Email: suppor[email protected]
USA:
Tel: [phone] (toll free)
Direct International Tel: [phone]
Email: T[email protected]

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 13
The Aperio GT 450 DX is a high performance, brighteld whole slide scanner that includes continuous loading with 450-slide
capacity across 15 racks, priority rack scanning, automated image quality check and a scan speed of ~32 seconds at 40x
scanning magnication for a 15 mm x 15 mm area.
The Aperio GT 450 DX is intended for use by trained clinical pathology histotechnicians, while the Aperio GT 450 SAM DX
software is intended for use by IT professionals and laboratory administrators.
The Aperio GT 450 DX is intended for use in medium- to high-volume clinical pathology laboratories that support the
pathology services of a hospital, reference laboratory or other clinical facility.
It is the responsibility of a qualied pathologist to employ appropriate procedures and safeguards to assure the validity of the
interpretation of images obtained using the Aperio GT 450 DX. Pathologists should exercise professional judgment in each
clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately
render an interpretation using this device alone.
Use of the Aperio GT 450 DX requires the following components.
Component Description
Scanner Administration Manager DX
(SAM DX) Server
The SAM DX server connects to multiple Aperio GT 450 DX scanners and runs
the SAM DX Application Software.
Scanner Administration Manager DX
(SAM DX) Application Software
The SAM DX client application software enables IT implementation, PIN
conguration, and service access of multiple scanners from a single desktop
client location for IT professionals.
Workstation, monitor, and keyboard A workstation, monitor, and keyboard must be connected to your local
area network with access to the SAM DX server to administer the GT
450 DX scanners.
See the Aperio GT 450 DX Specications for more information on these components.
Ensure you follow appropriate good laboratory practices and the policies and procedures required by your institution for slide
preparation, processing, storage, and disposal. Use this equipment only for this purpose and in the manner described in this
guide.
1 Introduction

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 202214
Chapter 1: Introduction
Resources
Resource Description
Aperio GT 450 DX User’s Guide Provides reference information and instructions for scanning, troubleshooting,
and maintenance.
Aperio GT 450 DX Quick Reference
Guide
Contains quick instructions for scanning, basic troubleshooting, and
maintenance. We recommend keeping this printed guide with your scanner.
An electronic version of the quick reference guide is available from the Help area
on the scanner’s touchscreen interface.
Aperio GT 450 DX IT Manager and Lab
Administrator Guide
Contains information and instructions regarding IT administration of the scanner,
including network administration and conguration.
Aperio GT 450 DX Specications Provides detailed specications for the scanner.
Instructional videos Provides video instruction on performing various tasks. You can view the videos
from the Help area on the scanner’s touchscreen interface.
Customer Support If you have an issue with the scanner you cannot resolve, contact Leica
Biosystems Technical Services. See “Customer Service Contacts” on page 11
for contact information.
Training Leica Biosystems offers classroom and virtual training courses. Contact Leica
Biosystems Customer Support for information about training options.
Warnings
This section contains important safety and operation warnings. Also refer to “Scanner Safety Instructions” on page 17.
Electromagnetic Warnings
If the scanner is used in any manner not specied in this documentation, the protection provided by the equipment may be
impaired.
CAUTION: Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the scanner, including
cables specied by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.
This device complies with the emissions and immunity requirements as specied in the EN/1EC 61326 series of Product
Family Standards for a “basic electromagnetic environment.” Such equipment is supplied directly at low voltage from public
mains network. This equipment is not intended for residential use.
This device generates, uses, and can radiate unintentional radio-frequency (RF) energy. If this device is not installed and
operated correctly, this RF energy can cause interference with other equipment. It is the responsibility of the end user to
be sure that a compatible electromagnetic environment for the device can be maintained so that the device operates as
intended.

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 15
Chapter 1: Introduction
This equipment is designed for use in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT. It is likely to perform
incorrectly if used in a HOME HEALTHCARE ENVIRONMENT. If it is suspected that performance is affected by electromagnetic
interference, correct operation may be restored by increasing the distance between the equipment and the source of the
interference.
In addition, other equipment can radiate RF energy to which this device is sensitive. If one suspects interference between this
device and other equipment, Leica Biosystems recommends the following actions to correct the interference:
`Evaluate the electromagnetic environment before installation and operation of this device.
`Do not operate this device close to sources of strong electromagnetic radiation (for example: unshielded intentional
RF sources), as these can interfere with proper operation. Examples of unshielded intentional radiators are handheld
radio transmitters, cordless phones, and cellular phones.
`Do not place this device near medical electrical equipment that can be susceptible to malfunctions caused by close
proximity to electromagnetic elds.
`This device has been designed and tested to CISPR 11 Class A emission limits. In a domestic environment, this
device can cause radio interference, in which case, you need to take measures to mitigate the interference.
Instrument Warnings
WARNING: To reduce the risk of re or electric shock, do not expose the scanner to rain or moisture.
Misuse of electrical equipment can cause electrocution, burns, res, and other hazards
Component and Part Replacement Warnings
There are no user-replaceable parts or components in the Aperio GT 450 DX. Replacement of parts or components within the
Aperio GT 450 DX must be performed by qualied Leica Biosystems Technical Services personnel using Leica Biosystems
specied parts.
CAUTION: Use of accessories, transducers and cables other than those specied or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
Compliance Specications
This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: (1) This device may
not cause harmful interference and (2) this device must accept any interference received, including interference that may
cause undesired operation.
This device has been evaluated against and conforms to the following standards:

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 202216
Chapter 1: Introduction
Feature Details
Safety
IEC 61010-1:2010
IEC 61010-1: 2010/AMD1:2016
IEC 61010-2-101: 2018
CAN/CSA C22.2 No. 61010-1:2012/A1:2018
CAN/CSA C22.2 No. 61010-2-101:2019
UL 61010-1:2012/R2019-07
UL 61010-2-101:2019
EN 61010-1:2010/A1:2019
EN 61010-2-101:2017
EMC EMC Directive (Directive 2014/30/EU)
EN 61326-1:2013
CISPR 11: 2015
FCC Part 15 Subpart B
ICES-003 Issue 6: 2016
CNS13438: 2006
KN 32: 2015-12
KN 35: 2015-12
Installation
WARNING: Two people are required for lifting the scanner.
Installation and setup of the scanner should only be performed by a trained Leica Biosystems Service representative. After
installation, the Leica Biosystems Service representative will check the scanner for proper operation.
WARNING: Incorrect installation could result in serious injury to the operator or ergonomic strain. Refer to
Aperio GT 450 DX Specications, MAN-0479 for work surface and operating specications.

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 17
Chapter 1: Introduction
When you rst receive the Aperio GT 450 DX and accessories, inspect the pallet and attached boxes for any damage.If the
package has visible damage from shipment, contact Leica Biosystems Customer Service for assistance.
Disposal of the Aperio GT 450 DX
The Aperio GT 450 DX is regulated as Electrical and Electronic Equipment Waste (WEEE) under 2012/19/EU and must be
discarded under special conditions. Contact Leica Biosystems, Inc. for assistance or questions regarding device disposal.
Device Lifetime
The lifetime of the Aperio GT 450 DX is ten years.
Scanner Safety Instructions
This section contains important safety information for the Aperio GT 450 DX.
When using your scanner, always take basic safety precautions, including all of those listed below.
`Read All Instructions – All safety and operating instructions must be read before operating the product.
`Retain All Instructions – All safety and operating instructions must be retained for future reference.
`Heed All Warnings – All warnings on the scanner and those listed in the operating instructions must be adhered to.
`Follow All Instructions – All operating and scanner usage instructions must be followed.
1. Heat – The scanner must be situated away from any heat sources such as radiators, heat registers, stoves, or other
products that produce heat.
2. Ventilation – Slots and openings in the scanner are provided for ventilation. They ensure reliable operation of the
product, keeping it from overheating. These openings must not be blocked nor covered during operation. Keep
air openings free of lint, hair, uff, etc. This product should not be placed into a rack unless proper ventilation is
provided through following the manufacturer’s recommended installation procedures.
3. Biosafety Procedures – Please refer to your institution’s biosafety policies and procedures regarding the proper
handling of tissue and other potentially hazardous materials in connection with the use of this device.
4. Water and Moisture – Do not use the scanner near water—for example, near a water bath, wash bowl, kitchen sink,
or laundry tub; in a wet basement; or near an open pool of water or the like. If the scanner becomes wet, unplug it
before touching it.
5. Environment - This device is intended for indoor use only.
6. Attachments – Do not use any attachments not recommended by the product manufacturer as they may cause
hazards.
7. Power Sources – The scanner must be operated from the type of power source indicated on the marking label and in
the installation instructions. If you are not sure of the type of power supplied to your facility, consult your local power
company. Check that the voltage setting matches the electrical supply voltage.
8. Grounding and Polarization – The scanner AC/DC adapter is equipped with a polarized AC plug with integral safety
ground pin. Do not defeat the safety ground in any manner.
9. Cable Protection – Secure all external cables to avoid operator injury.

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 202218
Chapter 1: Introduction
10. Power Cord Protection – Power supply cords must be routed so that they are not likely to be walked on nor pinched
by items placed upon or against them. Pay particular attention to the cords at AC wall plugs and convenience
receptacles and at the point where the cord enters the AC/DC adapter. The appliance coupler on the external AC/DC
power supply is considered the mains disconnect device.
11. Lightning – For added protection for this scanner during a lightning storm, or when it is left unattended and unused
for long periods of time, unplug it from the AC wall outlet. This will prevent damage to the product due to lightning
and power line surges.
12. Power Overloading – Do not overload AC wall outlets, extension cords, or integral convenience outlets as this can
result in a re or electric shock hazard.
13. Operating Environment – Observe these basic safety requirements. Do not operate the scanner out of doors.
`Do not use where aerosol sprays are being used or where oxygen is being administered.
`Do not let the scanner or its cables or accessories come into contact with surfaces which are too hot to touch.
`Do not place anything on top of the scanner.
14. Object and Liquid Entry – Never push objects of any kind into the scanner through openings as they may touch
dangerous voltage points or short-out parts that could result in a re or electric shock. Never spill liquid of any kind
on the scanner.
15. Accessories – Do not place the scanner on an unstable cart, stand, tripod, bracket, or table or the scanner may fall,
causing serious injury and damage to the product. Any mounting of the scanner needs to follow manufacturer’s
installation instructions. Do not place anything on top of the scanner.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation.
16. Moving – Use care if you must slide the scanner around the workbench. If you need to pick up the scanner to move
it off the workbench, contact Leica Biosystems Technical Services. Moving the scanner may void the applicable
product warranty—contact Leica Biosystems for advice.
17. Servicing – Refer all servicing to qualied service personnel.
18. Damage Requiring Service – Unplug the scanner from the wall AC outlet and refer servicing to qualied service
personnel under the following conditions:
`When the AC cord or AC/DC adapter is damaged.
`If liquid has been spilled or objects have fallen into the scanner.
`If the scanner has been exposed to rain or water.
`If the scanner does not operate normally (when you are following operating instructions).
`If the scanner has been dropped or damaged in any way.
`When the scanner exhibits a distinct change in performance. This indicates a need for service.
19. Replacement Parts – When replacement parts are required, be sure the service technician has used replacement

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022 19
Chapter 1: Introduction
parts specied by the manufacturer. Unauthorized substitutions may result in re, electric shock, or other hazards
and may affect product compliance.
The objective in the GT 450 DX scanner has been specically designed for this device. Do not replace it with another
type of objective.
WARNING: Use of accessories, transducers and cables other than those specied or provided
by the manufacturer of this equipment could result in increased electromagnetic emissions
or decreased electromagnetic immunity of this equipment and result in improper operation.
Unauthorized substitutions may result in re, electric shock, or other hazards and may affect
product compliance.
20. Operational Check – Upon completion of any repairs to this scanner, ask the service technician to perform operation
checks to determine that the product is in proper operating condition.
21. Cleaning – Apply the recommended cleaning solution to a clean cloth to clean the equipment. Do not apply cleaning
solutions directly to the equipment.
.

Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 202220
This chapter provides an overview of the Aperio GT 450 DX Scanner.
Theory of Operation
The Aperio GT 450 DX scanner contains an automated slide loader subsystem which is designed to process standard 1” X 3”
(2.54 cm x 7.62 cm) microscope slides.
The scanner automatically loads the slides from the slide racks that the technician loaded into the scanner carousel. The
slides are moved onto the scanning stage based on the automated processing and queueing of the racks.
Once the slide is on the stage, the imaging process begins with capturing the macro image, automatically detecting tissue,
automatic placement of initial focus points (and reference stripe location), capturing label image (including any barcode), and
the image acquisition is initiated.
The tissue nding and scanning processes are automated without any need for the user to manipulate the slides being
processed. If there is a need based on the quality review of the scanned image or tissue nder results, the device has the
capability to reinitiate the scan with a different user selected mode (entire slide scan). The device images the slide using
transmitted light from the Koehler Light Source through the specimen to the optical path (including the objective, tube
lens, apertures, and mirrors). At this point the light travels to the line scan camera where the imaging data is captured and
processed. The Aperio GT 450 DX scanner acquires images in stripes, as the motion subsystem moves the slide across
the Koehler and optical path. These stripes of data are processed in the control VPU and sent to a database for use in later
pathology workow steps. Once the slide has nished scanning, it is automatically removed from the stage, returned to the
slide rack and the next slide is loaded.
2 Aperio GT 450 DX Overview